Is a study ethical, just because it’s legal?

There was a furious debate (here and here) that occurred in social media spheres today when a company, called uBiome, defended its decision to not seek ethical review, by an Institutional Review Board (IRB), prior to designing a study to characterize the human microbiome and prior to seeking money to support the work from people via a crowdfunding website. Because the job of IRBs is to consider the known and potentially unknown ethical implications of a planned study – as well as to suggest meaningful remedies for any undue burdens on the participants or on society at large, this review generally helps to ensure that the conduct of a study is ethical.

We were informed (correctly) that IRBs are only required for federally funded projects, clinical trials, and those who seek publication in peer-reviewed journals. That’s right — projects that don’t want federal money, FDA approval, or to publish in traditional journals require no ethical review at all as far as we know.

In other words, because they were not seeking money from the federal government and because they were not planning to ultimately publish their discoveries in a scientific journal, they were not legally required to conduct an IRB review at that stage. What they fail to mention, of course, is that those very facts are why it is so important that groups like them need IRB oversight. Their study was privately funded and was not intended for publication. This means, more or less, that it was intended solely to lead to discoveries that could make them money. The motivation to conduct research for personal profit is a factor that should inspire the greatest social demand for review and oversight, but uBiome slipped through a big gaping loop hole and proceeded without this review.

Once the furor started to build about their activities (here and here), uBiome hired a company that provides IRB services to conduct said review. In their post today, they told us nothing about the content of that review, how it was conducted or what measures were to be taken to safeguard the interest of the subjects in the study or the interests of the broader society. It’s their view, apparently, that we should trust them.

uBiome is being rightfully called out for their failure to understand that it was their obligation to act ethically, rather than simply legally, but this is not the only example of problematic behavior of this type.

A recent paper published on the open access journal PLOS One demonstrates this point, as well. In this study, young macaque monkeys were moved from their social groups into cages where they lived alone for some undetermined amount of time. After behavioral observations were made, the monkeys were physically restrained (i.e., grabbed and forcefully held still), with no prior sedation, anesthesia or pain killer, while a blood sample was collected and a needle was inserted into the lower parts of their vertebral column (spine) so that a sample of cerebrospinal fluid (the solution that bathes the brain and spinal cord) could be withdrawn. This medical procedure is sometimes conducted in human patients when their condition calls for it (and much less commonly in human research participants), but it is generally viewed as a procedure that is very painful – both while it is being conducted and long afterwards. People that experience pain as a result of the procedure receive pain relief, as needed. As I mentioned in a comment on this article:

Both are painful procedures, with lumbar puncture representing a particular risk to both the researcher collecting the sample and, importantly, to the animal. Lumbar puncture in human subjects – which many individuals report as very painful – is sometimes conducted in ambulatory settings with no sedation or anesthesia, but local pain block is typically used. Moreover, headaches, often intense in severity, are a common post-tap symptom. For these reasons, as well as to avoid the distress of physical restraint and the risk to the subject associated with a sudden movement while the needle is in place, chemical sedation or anesthesia are the standard of care in virtually every veterinary setting in the US, Canada and Europe (as well as many others).

The authors did not address the fact that their procedure violated the standards of care used by competent veterinarians. Instead, they said simply that:

The blood and CSF collections were of course performed by a trained and skilled veterinarian, used to work with macaques, both procedures classically performed in humans as well. They were approved by an IACUC…

In other words, they believe that the approval of the Institutional Animal Care and Use Committee (IACUC) that supervises their Chinese facility should allay any concerns about the ethical nature of their work.

What they really mean, of course, is that the IACUC approval makes their work legal and publishable (!), not that it makes it ethical. Determining the latter would require a detailed analysis of their reasoning behind depriving the monkeys of normal social interaction and subjecting them to an intensely painful procedure without pain relief. It requires an understanding of the discussion of the IACUC and whether it fully considered all the relevant facts and factors in play. Since this is a private facility that operates with almost no oversight, because the authors of the paper themselves have a financial interest in the company that conducted the research and because the work was conducted in a country with extremely lax regulations relating to animal welfare, there is ample reason to be worried about the ethics of a study like this.

Both uBiome and the authors of the PLOS One paper have some serious thinking to do about what it means to be an ethical scientist. As Janet Stemwedel pointed out in a tweet:

… laws should be the floor, not the ceiling, for ethical conduct…

I couldn’t agree more, and it’s essential that researchers stop hiding behind the minimum standards that the law requires and start operating like the ethical agents that society expects us to be.